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Ethical issues defined

To achieve either of these designations, the coordinator must sit for an examination following specified amounts of either full-time or part-time experience by the date of the examination as defined by either organization (www.acrpnet.org and www.socra.org). The examinations test knowledge in study conduct, regulations and ethical issues. [Pg.130]

One of the most famous of the Greek philosophers was Socrates (470-399 BC). The Socratic method is the name given to the process by which an argument starts from an incontrovertible statement based on common experience and is developed by means of clearly defined logical rules. Socrates was not concerned with the nature of matter or the structure of the universe his philosophy was concerned with moral and ethical issues. His aim was to deduce rules that would enable people to be good citizens and live together in peace. [Pg.8]

To address the ethical issues of maintaining communication between the Region and its patients, its providers, and its key partners and stakeholders, several policies were also developed to promote safety throrrgh communication and transparency in actions. To avoid corrfirsion over terminology, three types of cormnunication have been defined. Reporting relates to commimication between healthcare providers and the Region and concerns hazards and harm. Disclosure relates to communication... [Pg.37]

The group first discussed what safer means. Does it mean safety from terrorism, natural disasters, disease, hunger, etc. We can define safety specifically or broadly. Defined broadly, safety concerns are related to inequahties in the way basic human needs across the world are met. These inequalities make the world an unsafe place. Engineers need to be aware of political and ethical issues of inequality in the United States and abroad and become more involved in policy making to address these issues at the local and national levels. [Pg.146]

Over the years, scientific research with human subjects has provided valuable information to help characterize and control risks to public health, but its use has also raised particular ethical concerns for the welfare of the human participants in such research as well as scientific issues related to the role of such research in assessing risks. Society has responded to these concerns by defining general standards for conducting human research. As an example, studies carried out for the authorization of a medical product, have to be conducted in line with the World Medical Association s Declaration of Helsinki, which describes the general ethical principles for medical research involving human subjects (World Medical Association 2004). The Helsinki Declaration was first issued by the World Medical Association in 1964 and has been revised several times since then. [Pg.51]

In addition to the Nuremberg Code and Declaration of Helsinki, The International Ethical Guidelines for Biomedical Research Involving Human Subjects was issued in 1982 and revised in 1993 by the Council for the International Organization of Medical Sciences (CIOMS). Those guidelines define national policies for biomedical research, apply ethical standards to the circumstances often present in research in economically developing nations, and define mechanisms for ethical review of human subjects research. [Pg.74]

Multiple studies have attempted to address the issue of incidence of acute phosphate nephropathy. During calender year 2005, C.B. Fleet, a large producer of OSPS, reported 10 serious adverse events (SAE) for every 1,000,000 doses sold, but did not specify how many of these involved the kidney [66]. Clearly, the overwhelming majority of SAE s are unreported. The relatively small number of enrolled patients significantly flaws prospective studies of APhN, and ethical considerations may limit the ability to perform prospective stiidies.Retrospective studies may be flawed if they are underpowered, do not take into account biases in selection of bowel preparation, and do not appropriately define renal failure [67, 68]. [Pg.590]

There are clearly ethical concerns to manipulation of the human genome. These must be addressed, taking into account all potential benefits and risks involved. These include the nature of the society that might result from such tinkering with the very molecules that define our species. The jury is out on these issues as the recent debates with stem cells and cloning clearly illustrate. [Pg.154]

The Durham Humphrey Amendment (1951) defined the kinds of drugs that required medical supervision for safe use and restricted them to sale by prescription. Two years later, in 1953, the US Public Health Service issued a policy document entitled Group Consideration of Clinical Research Procedures Deviating from Accepted Medical Practice or Involving Unusual Hazard. This policy stated that the potential risks of clinical studies must be carefully assessed and that informed consent was essential. Ethical review of research proposals was also suggested. In this same year, the Factory Inspection Amendment was passed, requiring the FDA to give written inspection reports to manufacturers. [Pg.86]

In assessing the significance of different types of pollution, it is useful to classify them in terms of their spatio-temporal impacts. The spatial dimension defines the extent of the ecosystem impacted (and therefore also the population affected) by the pollutant in question, while the temporal aspect takes into account the kinetics of the impact. Spatial effects are easier to estimate and where needed, weighted to take into account any effects on human health. Temporal impacts are far more difficult to quantify as the impacts are felt by different populations or even different generations. The fact that the polluter and the affected can be so maikedly separated in space and time introduces an ethical dimension to environmental issues. Generally, consumers tend to pay more attention to the needs of the present generation compared to future generations. [Pg.23]


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Ethical issues

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